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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K091574
Device Name SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES
Applicant
SUPPLIDORES UNIDOS INTERNACIONALES, S.A.
PO BOX 97-0132
COCONUT CREEK,  FL  33067 -2366
Applicant Contact VICTOR PEREIRA
Correspondent
SUPPLIDORES UNIDOS INTERNACIONALES, S.A.
PO BOX 97-0132
COCONUT CREEK,  FL  33067 -2366
Correspondent Contact VICTOR PEREIRA
Regulation Number878.5000
Classification Product Code
GAT  
Date Received06/02/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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